Viewing Study NCT00235157



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Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00235157
Status: COMPLETED
Last Update Posted: 2008-08-06
First Post: 2005-10-06

Brief Title: A Comparison of Coated and Uncoated Stents in Renal Artery Treatment
Sponsor: Cordis Corporation
Organization: Cordis Corporation

Study Overview

Official Title: Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment
Status: COMPLETED
Status Verified Date: 2008-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GREAT
Brief Summary: The primary objective of this study is to compare the safety and performance of the Palmaz Genesis balloon expandable stent with or without sirolimus coating in the treatment of renal artery stenosis measured at 6 months follow up via angiography
Detailed Description: Multi-center prospective controlled non-randomized investigational feasibility study One hundred 100 patients with de novo or restenotic renal artery lesions consisting of 50 stenosis and reference vessel of 40 to 80 mm in diameter will be sequentially included 50 without sirolimus coating followed by 50 with sirolimus coating Palmaz GenesisTM Patients will be followed for 24 months post-procedure with all patients having clinical assessments at discharge 16 12 and 24 months This study will be conducted at twelve investigational sites

It is anticipated that the total length of time required to complete the study will be 46 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None